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ODAC Backs Random Sample Audits Of Progression Events

 
• By Sue Sutter

FDA’s Oncologic Drugs Advisory Committee supports easing the current requirement for blinded, independent central review of 100% of patient scans in studies using progression-free survival as the primary endpoint. However, committee members say FDA needs the flexibility to require full case audits in certain circumstances, depending upon tumor type and study size.

Independent review of study investigators’ progression assessments in only a subgroup of patients is a feasible strategy for oncology trials, but may not be appropriate in all cases, FDA’s Oncologic Drugs Advisory Committee said July 24.

While ODAC members endorsed the concept of auditing only a random subgroup of patients’ scans, they said 100% review may...

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More from United States

PDUFA VIII: FDA Pilot Programs, Workforce Challenges Could Shape Renewal Debate

 
• By Sue Sutter

The next iteration of the user fee program could depart from longstanding agency commitments to issue formal guidance given the Trump Administration’s deregulatory philosophy, policy experts said.

US FDA ANDA Priority Pilot ‘Practically Unusable’ Without Tweaks, AAM CEO Says

 
• By Sarah Karlin-Smith

Association for Accessible Medicines CEO John Murphy told the Pink Sheet that the FDA may need to consider phasing in the requirements for the new ANDA priority voucher incentive program if it wants sponsors to apply in the near-term.

US FDA Begins ‘Competitive Search’ For New Drugs Center Director

 
• By Derrick Gingery and Sarah Karlin-Smith

The FDA deputy commissioner emailed staff asking anyone interested in the position to send her their curriculum vitae, an unusual method for finding candidates for a high-level position.

Pink Sheet Podcast: Examining George Tidmarsh’s Departure As Head Of US FDA’s Drug Center

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors explain Tidmarsh’s abrupt resignation as the FDA’s chief drug regulator and the potential impact on the already reeling agency.

More from North America

FDA Office of New Drugs Director Mary Thanh Hai Not Interested In CDER Director Job

 
• By Sue Sutter

The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.

Novo, Lilly Lower GLP-1 Prices, ‘Enabling’ Medicare, Medicaid Coverage In Obesity

 
• By Cathy Kelly

The $245 price agreed to by both firms may be in line with the maximum fair price that Medicare negotiated for Novo Nordisk’s semaglutide products.

Oz: CMS Developing Plans To Incentivize Domestic Manufacturing

 
• By Sarah Karlin-Smith

The Trump Administration’s efforts to encourage more US-based pharmaceutical manufacturing have largely centered on FDA plans and Trump’s threats of tariffs and Most Favored Nation pricing, but Oz hinted Medicare and Medicaid soon may soon announce new incentives.